Oral Dosage Form New Animal Drugs; Amprolium Solution, 56346-56347 [06-8275]

Download as PDF 56346 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR part 70. PART 70—DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 520 Oral Dosage Form New Animal Drugs; Amprolium Solution I 1. The authority citation for part 70 continues to read as follows: AGENCY: Authority: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 953, 954, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 Stat. 2835 as amended by Pub. L. 104–134, 110 Stat. 1321, 1321–349 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note). Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141, Pub. L. 97–425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 70.7 also issued under Pub. L. 95–601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851). Section 70.21(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. L. 93–377, 88 Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 70.44 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 70.81 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). Section 70.82 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138). ACTION: HHS. 2. In § 70.72, paragraph (c)(2) is revised to read as follows: I § 70.72 Facility changes and change process. * * * * * (c) * * * (2) Does not remove, without at least an equivalent replacement of the safety function, an item relied on for safety that is listed in the integrated safety analysis summary and is necessary for compliance with the performance requirements of § 70.61; * * * * * Dated at Rockville, Maryland, this 13th day of September 2006. For the Nuclear Regulatory Commission. Luis A. Reyes, Executive Director for Operations. [FR Doc. 06–8270 Filed 9–26–06; 8:45 am] sroberts on PROD1PC70 with RULES BILLING CODE 7590–01–P VerDate Aug<31>2005 16:20 Sep 26, 2006 Jkt 208001 Food and Drug Administration, Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (ANADA) filed by IVX Animal Health, Inc. The ANADA provides for use of amprolium solution to make medicated drinking water or as a drench for the prevention or treatment of coccidiosis in calves. DATES: This rule is effective September 27, 2006. FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for Veterinary Medicine (HFV–104), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301–827-0169, email: john.harshman@fda.hhs.gov. SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th Street Ter., St. Joseph, MO 64503, filed ANADA 200–389 that provides for the use of Amprolium 9.6% Oral Solution to make medicated drinking water or as a drench for the prevention or treatment of coccidiosis in calves. IVX Animal Health’s Amprolium 9.6% Oral Solution is approved as a generic copy of Merial Ltd.’s CORID (amprolium) 9.6% Solution approved under NADA 13– 149. The ANADA is approved as of September 6, 2006, and the regulations are amended in 21 CFR 520.100 to reflect the approval and a current format. The basis of approval is discussed in the freedom of information summary. In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 nor an environmental impact statement is required. This rule does not meet the definition of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because it is a rule of ‘‘particular applicability.’’ Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808. List of Subject in 21 CFR Part 520 Animal drugs. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is amended as follows: PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS 1. The authority citation for 21 CFR part 520 continues to read as follows: I Authority: 21 U.S.C. 360b. I 2. Revise § 520.100 to read as follows: § 520.100 Amprolium. (a) Specifications—(1) Each milliliter of solution contains 96 milligrams (mg) amprolium (9.6 percent solution). (2) Each gram of powder contains 200 mg amprolium (20 percent). (3) Each ounce (28.4 grams) of crumbles contains 355 mg amprolium (1.25 percent). (b) Sponsors. See sponsors in § 510.600(c) of this chapter. (1) No. 050604 for use of products described in paragraph (a) of this section as in paragraph (e) of this section. (2) No. 051311 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section. (3) No. 059130 for use of product described in paragraph (a)(1) of this section as in paragraph (e)(2) of this section. (c) Related tolerances. See § 556.50 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use—(1) Chickens and turkeys. It is used in drinking water as follows: (i) Amount. Administer at the 0.012 percent level in drinking water as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in severe outbreaks, give amprolium at the 0.024 percent level); continue with 0.006 percent amproliummedicated water for an additional 1 to 2 weeks. (ii)Indications for use. For the treatment of coccidiosis. (iii) Limitations. Use as the sole source of amprolium. (2) Calves. Administer crumbles topdressed on or thoroughly mixed in the E:\FR\FM\27SER1.SGM 27SER1 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations daily feed ration; administer concentrate solution or soluble powder as a drench or in drinking water as follows: (i) Indications for use and amounts— (A) As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, administer 5 mg per kilogram (mg/kg) body weight in drinking water for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard. (B) As an aid in the treatment of coccidiosis caused by E. bovis and E. zuernii, administer 10 mg/kg body weight in drinking water for 5 days. (ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Use as the sole source of amprolium. § 520.100a I 3. Remove § 520.100a. § 520.100b I [Removed] 4. Remove § 520.100b. § 520.100c I [Removed] [Removed] I. Background 5. Remove § 520.100c. Dated: September 18, 2006. Bernadette A. Dunham, Acting Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. [FR Doc. 06–8275 Filed 9–26–06; 8:45 am] BILLING CODE 4160–01–S OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION 29 CFR Part 2201 Regulations Implementing the Freedom of Information Act Occupational Safety and Health Review Commission. ACTION: Final rule. sroberts on PROD1PC70 with RULES AGENCY: SUMMARY: The Occupational Safety and Health Review Commission (OSHRC) revises its regulations implementing the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended. The regulations contain new provisions to comply with Executive Order 13392. In addition, the regulations have been updated to reflect changes in OSHRC’s policies and procedures. As a result of these revisions, the public will have a clearer understanding of OSHRC’s policies and procedures implementing the FOIA. DATES: This rule is effective on October 27, 2006. FOR FURTHER INFORMATION CONTACT: Jin H. Kim, Attorney-Advisor, Office of the General Counsel, 1120 20th Street, NW., VerDate Aug<31>2005 16:20 Sep 26, 2006 Ninth Floor, Washington, DC 20036– 3457. Telephone: (202) 606–5410. Fax: (202) 606–5417. E-mail: jkim@oshrc.gov. SUPPLEMENTARY INFORMATION: OSHRC is publishing a final rule for regulations implementing the FOIA. On July 21, 2006, OSHRC published for comment a notice of proposed rulemaking (NPRM) in the Federal Register that proposed revisions to OSHRC’s regulations at 29 CFR part 2201, implementing the FOIA, 5 U.S.C. 552, as amended. 71 FR 41384, Jul. 21, 2006. Interested persons were afforded an opportunity to participate in the rulemaking process through submission of written comments on the NPRM. OSHRC received no public comments. OSHRC has reviewed the proposed regulations and has only changed the regulatory text in this final rule to update the contact information in 29 CFR 2201.3(d), correct the crossreferences in 29 CFR 2201.4(c) and (d), and add cross-references to Appendix A in 29 CFR 2201.7. All other provisions in the regulatory text are the same as in the NPRM, and OSHRC adopts them in this final rule. Jkt 208001 As mentioned in the preamble to the proposed regulations, OSHRC is making several substantive and technical revisions to its regulations to (1) Comply with Executive Order 13392 (E.O. 13392), 70 FR 75373, Dec. 19, 2005, (2) reflect recent changes in OSHRC’s policies and procedures as they relate to the processing of FOIA requests, and (3) make purely technical or clarifying changes in phrasing and nomenclature. 71 FR 41384, Jul. 21, 2006. OSHRC’s revisions to its FOIA regulations, including the addition of new provisions and the modification of existing provisions, comply with the requirements of E.O. 13392. See 70 FR at 41384–85. In issuing E.O. 13392, the President directed each agency to ensure that its FOIA operations are ‘‘citizen-centered’’ and ‘‘resultsoriented.’’ In order to achieve these goals, E.O. 13392 requires each agency head to designate a Chief FOIA Officer, who has agency-wide responsibility for the efficient and appropriate compliance with the FOIA. As part of his or her duties under E.O. 13392, the Chief FOIA Officer must review the agency’s FOIA operations and identify any areas for improvement. In addition, E.O. 13392 requires agencies to establish FOIA Requester Service Centers to enable any FOIA requester to seek information concerning the status of his or her FOIA request, as well as appropriate information about the agency’s FOIA response. E.O. 13392 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 56347 further requires agencies to designate, as part of the FOIA Requester Service Center, FOIA Public Liaisons to serve as the supervisory officials to whom a FOIA requester can raise concerns about the service the FOIA requester has received from the FOIA Requester Service Center, following an initial response to the FOIA request. Therefore, OSHRC revises its regulations implementing the FOIA to comply fully with E.O. 13392. Furthermore, based on the Chief FOIA Officer’s review of OSHRC’s FOIA operations, OSHRC also proposed revisions to its rule to reflect recent changes in OSHRC’s policies and procedures as they relate to the processing of FOIA requests. As mentioned in the preamble to the NPRM, OSHRC moved all FOIA processing from its Office of Administration to the Office of the General Counsel at the beginning of this fiscal year (FY 2006). 71 FR at 41385. Currently, paralegals and attorneys, who have received specialized FOIA training, are now handling all FOIA requests. These revised regulations reflect changes in OSHRC’s policies and procedures, which will make the processing of FOIA requests more efficient and responsive. Finally, as specified in the preamble to the NPRM, OSHRC revises its regulations to correct grammatical errors, change nomenclature, renumber sections and paragraphs as a result of deleting and adding sections and paragraphs to the regulations, update regulatory cross-references, and clarify sentences. 71 FR at 41384–87. II. Section-by-Section Analysis OSHRC revises § 2201.1 to correct a grammatical error in the section heading and to add abbreviations for OSHRC and FOIA. OSHRC has also made similar changes throughout the regulations and corrected other grammatical errors, as well as changed nomenclature, such as FOIA Disclosure Officer, and updated regulatory cross-references. 71 FR at 41384–88. In § 2201.2, OSHRC adds a sentence to the end of the section to provide additional details about the designation of one of the Commissioners as the Chairman and his responsibilities for the administrative operations of the Commission. This is consistent with section 12(e) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 661(e). OSHRC revises the delegation of FOIA-related duties in § 2201.3 to reflect the changes required by E.O. 13392. First, in paragraph (a), the Chairman delegates to the Chief FOIA E:\FR\FM\27SER1.SGM 27SER1

Agencies

[Federal Register Volume 71, Number 187 (Wednesday, September 27, 2006)]
[Rules and Regulations]
[Pages 56346-56347]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-8275]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Amprolium Solution

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a new animal drug application 
(ANADA) filed by IVX Animal Health, Inc. The ANADA provides for use of 
amprolium solution to make medicated drinking water or as a drench for 
the prevention or treatment of coccidiosis in calves.

DATES: This rule is effective September 27, 2006.

FOR FURTHER INFORMATION CONTACT: John K. Harshman, Center for 
Veterinary Medicine (HFV-104), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0169, e-mail: 
john.harshman@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: IVX Animal Health, Inc., 3915 South 48th 
Street Ter., St. Joseph, MO 64503, filed ANADA 200-389 that provides 
for the use of Amprolium 9.6% Oral Solution to make medicated drinking 
water or as a drench for the prevention or treatment of coccidiosis in 
calves. IVX Animal Health's Amprolium 9.6% Oral Solution is approved as 
a generic copy of Merial Ltd.'s CORID (amprolium) 9.6% Solution 
approved under NADA 13-149. The ANADA is approved as of September 6, 
2006, and the regulations are amended in 21 CFR 520.100 to reflect the 
approval and a current format. The basis of approval is discussed in 
the freedom of information summary.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and 
effectiveness data and information submitted to support approval of 
this application may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    FDA has determined under 21 CFR 25.33(a)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the congressional review requirements 
in 5 U.S.C. 801-808.

List of Subject in 21 CFR Part 520

    Animal drugs.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  520.100 to read as follows:


Sec.  520.100  Amprolium.

    (a) Specifications--(1) Each milliliter of solution contains 96 
milligrams (mg) amprolium (9.6 percent solution).
    (2) Each gram of powder contains 200 mg amprolium (20 percent).
    (3) Each ounce (28.4 grams) of crumbles contains 355 mg amprolium 
(1.25 percent).
    (b) Sponsors. See sponsors in Sec.  510.600(c) of this chapter.
    (1) No. 050604 for use of products described in paragraph (a) of 
this section as in paragraph (e) of this section.
    (2) No. 051311 for use of product described in paragraph (a)(1) of 
this section as in paragraph (e)(1) of this section.
    (3) No. 059130 for use of product described in paragraph (a)(1) of 
this section as in paragraph (e)(2) of this section.
    (c) Related tolerances. See Sec.  556.50 of this chapter.
    (d) Special considerations. See Sec.  500.25 of this chapter.
    (e) Conditions of use--(1) Chickens and turkeys. It is used in 
drinking water as follows:
    (i) Amount. Administer at the 0.012 percent level in drinking water 
as soon as coccidiosis is diagnosed and continue for 3 to 5 days (in 
severe outbreaks, give amprolium at the 0.024 percent level); continue 
with 0.006 percent amprolium-medicated water for an additional 1 to 2 
weeks.
    (ii)Indications for use. For the treatment of coccidiosis.
    (iii) Limitations. Use as the sole source of amprolium.
    (2) Calves. Administer crumbles top-dressed on or thoroughly mixed 
in the

[[Page 56347]]

daily feed ration; administer concentrate solution or soluble powder as 
a drench or in drinking water as follows:
    (i) Indications for use and amounts--(A) As an aid in the 
prevention of coccidiosis caused by Eimeria bovis and E. zuernii, 
administer 5 mg per kilogram (mg/kg) body weight in drinking water for 
21 days during periods of exposure or when experience indicates that 
coccidiosis is likely to be a hazard.
    (B) As an aid in the treatment of coccidiosis caused by E. bovis 
and E. zuernii, administer 10 mg/kg body weight in drinking water for 5 
days.
    (ii) Limitations. Withdraw 24 hours before slaughter. A withdrawal 
period has not been established for this product in preruminating 
calves. Do not use in calves to be processed for veal. Use as the sole 
source of amprolium.


Sec.  520.100a  [Removed]

0
3. Remove Sec.  520.100a.


Sec.  520.100b  [Removed]

0
4. Remove Sec.  520.100b.


Sec.  520.100c  [Removed]

0
5. Remove Sec.  520.100c.

    Dated: September 18, 2006.
Bernadette A. Dunham,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 06-8275 Filed 9-26-06; 8:45 am]
BILLING CODE 4160-01-S

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